Oxytocin versus prostaglandins for labour Induction of women with an unfavourable cervix after 24 hours of cervical ripening (OPIC): protocol for an open multicentre randomised non-inferiority trial

What Was Tested

This clinical study paper looks at Oxytocin.

It remains uncertain whether the most appropriate management for women with an unfavourable cervix after 24 hours of cervical ripening is repeating the ripening procedure or proceeding directly to induction by oxytocin.

No adequately powered trial has compared these strategies.

Who Took Part

PubMed tags the participants as women only.

Exclusion criteria comprise being in labour, having more than 3 contractions per 10 min, or a prior caesarean delivery or a history of uterine surgery, or a fetus with antenatally suspected severe congenital abnormalities or a non-reassuring fetal heart rate.

How the Study Was Run

The design is described as randomized, open-label and multicenter.

Random assignment meant chance, not the researchers, decided who got Oxytocin and who got the comparison, which limits bias.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

More than one site took part, so the participants came from several places.

The primary endpoint will be the caesarean delivery rate, regardless of indication.

Secondary outcomes concern delivery, perinatal morbidity, maternal satisfaction and health economic evaluations.

What Was Measured

Topics PubMed links to this paper include Abortifacient Agents, Nonsteroidal, Cervical Ripening, Cervix Uteri, Dinoprostone, Labor, Induced, Oxytocics and Oxytocin.

The authors tagged it with the keywords maternal medicine, organisation of health services and protocols & guidelines.

What This Means in Plain Language

The paper is a randomized, open-label and multicenter study of Oxytocin.

The publication is from 2023 (BMJ open), a journal based in England.

More context: the Oxytocin compound page, all human trials.